Document Detail


Should HBV DNA NAT replace HBsAg and/or anti-HBc screening of blood donors?
MedLine Citation:
PMID:  14980546     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Prevention of transfusion-transmitted hepatitis B virus (HBV) has historically relied on serological screening of blood donors using progressively more sensitive HBsAg assays; in some countries anti-HBc assays have also been employed to detect chronic carriers with low-level viremia who lack detectable HBsAg. Nucleic acid amplification testing (NAT) for HCV and HIV has been successfully introduced to screen donors in many developed countries over the past several years; for logistical and cost reasons HCV/HIV NAT screening has been applied to mini-pools (MP) of eight to 96 donor specimens, with only minimal impact of MP dilutions on clinical sensitivity for interdiction of window period (WP) donations. In several countries (e.g., Japan and Germany), HBV NAT has been added to HIV/HCV MP-NAT blood donor screening with small incremental yields of HBsAg/anti-HBc-negative donations, and the major vendors of NAT systems (Roche and Chiron/Gen-Probe) have been developing triplex assays that include HBV DNA detection capacity without compromising HIV or HCV detection. Pooled specimen HBV NAT has also become the standard of practice for screening source plasma donors, with pressure to include HBV DNA detection as a required procedure for use of recovered plasma in manufacture of fractionated derivatives. However, there is controversy over the magnitude of the incremental yield and clinical benefit of HBV MP-NAT over serological screening strategies, as well as the impact of implementation of HBV NAT on need for retention of HBsAg and anti-HBc screening. This presentation will review recent modeled and empirical data on the value of HBV MP- and individual donation (ID)-NAT for detection of (1) pre-HBsAg WP units and (2) chronic anti-HBc-reactive carriers with undetectable HBsAg. The presentation will also review policy considerations and data that address the potential for discontinuation of either HBsAg or anti-HBc following implementation of HBV NAT. Finally it will address the cost effectiveness of incorporation of HBV DNA detection into HBV screening and NAT testing algorithms.
Authors:
Michael P Busch
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Transfusion clinique et biologique : journal de la Société française de transfusion sanguine     Volume:  11     ISSN:  1246-7820     ISO Abbreviation:  Transfus Clin Biol     Publication Date:  2004 Feb 
Date Detail:
Created Date:  2004-02-24     Completed Date:  2004-04-29     Revised Date:  2005-11-16    
Medline Journal Info:
Nlm Unique ID:  9423846     Medline TA:  Transfus Clin Biol     Country:  France    
Other Details:
Languages:  eng     Pagination:  26-32     Citation Subset:  IM    
Affiliation:
Blood Systems Research Institute, University of California, 270 Masonic Avenue, San Francisco, CA 94904, USA. mpbusch@itsa.ucsf.edu
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MeSH Terms
Descriptor/Qualifier:
Blood Donors*
Blood Transfusion / adverse effects,  standards*
Communicable Disease Control / organization & administration*,  standards
Cost-Benefit Analysis
DNA, Viral / blood*
Hepatitis B / blood,  diagnosis*
Hepatitis B Antibodies / blood
Hepatitis B Surface Antigens / blood
Hepatitis B virus / genetics,  isolation & purification*
Humans
Mass Screening / economics,  methods*
Safety
Sensitivity and Specificity
Serologic Tests
Viral Load
Viremia / blood,  diagnosis*
Chemical
Reg. No./Substance:
0/DNA, Viral; 0/Hepatitis B Antibodies; 0/Hepatitis B Surface Antigens

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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